Senior Executive, Reg Affairs-ARPL-RA AR

4 hours ago

Bengaluru, India Apotex Full time

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: . Job Summary Preparation and review of original injectable product submissions, amendments, and annual reports to ensure completeness, sterility compliance, and regulatory adequacy of all documentation. Job Responsibilities Compilation, review and submission of ANDA/NDA (505b2)/ANDS/NDS for US, Canada markets for Injectables and Ophthalmic• Review and finalization of submissions as per respective regulatory guidelines and checklist• Compilation and review of sterility assurance package (section 32P35)• Compilation of Deficiency responses for regulatory submission.• Compilation, review and submission of post approval submissions (PAS/CBE-30/CBE/Supplements/Annual Notifications)• Execution of regulatory activities through various tools like, Docubridge, Livelink, RIMS, Trackwise, labelbridge etc.• Change control assessment for regulatory impact before implementation.• Interacting with supporting departments like R&D, QC, QA, production and AR&D etc. on issues related to RA for New submissions and deficiency responses.• Review of all technical documents required for compiling the new drug submissions, post approval submissions and query responses.• Relevant communication and follow ups with the respective customers required for compilation, submission and respective query responses.• Responsible for eCTD/RIMS activities of submissions• Works in a safe manner collaborating as a team member to achieve all outcomes.• All other relevant duties as assigned. Job Requirements Education Master’s degree in Science/Pharmacy Knowledge, Skills and Abilities Good command over MS-Office: Word, Power Point, Excel etc. Interacting with supporting departments like R&D, QC, QA, production and AR&D etc. on issues related to RA for submissions and deficiency responses. Experience 5-8 years’ experience in Regulatory Affairs At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.  We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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